MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R SERIES ALS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Device Problems Device Alarm System (1012); Battery Problem (2885); Protective Measures Problem (3015)

Patient Problem Asystole (4442)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

Post arrest patient was being transcutaneously paced with a zoll.The zoll was not plugged in and stopped working when the battery died.Patient went asystole, requiring 1 round of cpr, and then achieved return of spontaneous circulation.Through root cause analyses, product design issues were noted: the low battery display on the zoll is small and the low battery warning is the same tone as the pacing tone which was sounding at 80 bpm.

• Brand Name: ZOLL R SERIES ALS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA 01824
• MDR Report Key: 16399261
• MDR Text Key: 309893126
• Report Number: MW5115027
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female